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OXIS 12 TURBOHALER

Active substance(s): EFORMOTEROL FUMARATE DIHYDRATE / FORMOTEROL FUMARATE DIHYDRATE

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If you forget to use Oxis Turbohaler
• If you forget to take a dose, take it as soon as
you remember. However, if it is nearly time for
your next dose, skip the missed dose.
• Do not take a double dose to make up for a
forgotten dose.
If you stop using Oxis Turbohaler
Do not stop using Oxis Turbohaler without talking
to your doctor.
If you have any further questions on using your
Turbohaler, ask your doctor, nurse or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If the following happens to you, stop using
Oxis Turbohaler and talk to your doctor
immediately:
• Bronchospasm (tightening of the muscles in the
airways which causes sudden wheezing) after
inhaling your medicine. This happens very
rarely, may affect up to 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Palpitations (awareness of your heart beating),
trembling or shaking. If these effects occur, they
are usually mild and usually disappear as you
continue to use Oxis Turbohaler.
• Headache.
Uncommon (may affect up to 1 in 100 people)
• Feeling restless or agitated.
• Disturbed sleep.
• Fast heart beat.
• Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
• Uneven heart beat.
• Nausea (feeling sick).
• Low level of potassium in your blood.
• Allergic reactions such as rash, itching and
bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
• Chest pain or tightness in the chest (angina
pectoris).
• An increase in the amount of sugar (glucose) in
your blood.
• Taste changes, such as an unpleasant taste in
the mouth.
• Changes in your blood pressure.
• Feeling dizzy
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5.HOW TO STORE OXIS TURBOHALER

Assessed against UK leaflet dated November 2014
PATIENT INFORMATION LEAFLET
®

• Keep out of the sight and reach of children.
• Do not store above 30°C.
• When not in use, Oxis 12 Turbohaler should be
stored with the cover tightened.
• Do not use Oxis 12 Turbohaler after the expiry
date printed on the carton or on the side of your
Turbohaler. The expiry date refers to the last day
of that month.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are
no longer required. This will help to protect the
environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Oxis 12 Turbohaler contains
Each actuation contains 12 micrograms formoterol
fumarate dihydrate per metered dose,
corresponding to 9 micrograms per delivered
dose.
Your medicine also contains lactose.
What Oxis 12 Turbohaler looks like and
contents of the pack
Oxis 12 Turbohaler is a breath-actuated dry
powder inhaler with a jade green base and a white
plastic body and cover. A Braille code for
identification of formoterol is embossed at the
bottom of the turn grip.
Oxis 12 Turbohaler contains 60 actuations.
Manufacturer and Licence Holder
The Turbohaler is manufactured by AstraZeneca
AB, S-151 85 Sodertalje, Sweden, and is
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0862 - Oxis 12 Turbohaler

Oxis & Turbohaler are registered trademarks of
AstraZeneca AB.
Leaflet revision date: 23/06/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

OXIS 12 TURBOHALER

By majida at 12:21 pm, Aug 21, 2015
Ref: 0862/230615/1/F

®

(formoterol fumarate)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Oxis 12 Turbohaler is and what it is used
for
2. What you need to know before you use Oxis
12 Turbohaler
3. How to use Oxis 12 Turbohaler
4. Possible side effects
5. How to store Oxis 12 Turbohaler
6. Contents of the pack and other information
1. WHAT OXIS 12 TURBOHALER IS AND WHAT
IT IS USED FOR
Oxis Turbohaler is an inhaler. It contains a
medicine called formoterol. This belongs to a
group of medicines called
‘long-acting beta-agonists’ or ‘bronchodilators’.
It works by relaxing the muscles in your airways.
This helps you to breathe more easily. It starts to
work within 1 to 3 minutes and the effects last up
to 12 hours.
Your doctor has prescribed this medicine to treat
asthma or chronic obstructive pulmonary disease
(COPD).
Asthma
Oxis Turbohaler is used to treat asthma in adults,
adolescents and children aged 6 years and older.
For asthma, your doctor will prescribe two asthma
inhalers:
Oxis Turbohaler and a separate ‘corticosteroid’
inhaler.
These should be used together.
• Oxis Turbohaler is used to help prevent
asthma symptoms from happening.
• Some people also use Oxis Turbohaler when
they need extra doses for relief of asthma
symptoms, to make it easier to breathe again.
• Oxis Turbohaler can also be used before
exercise to prevent asthma symptoms caused
by exercise.
Chronic obstructive pulmonary disease
(COPD)
Oxis Turbohaler can also be used to treat the
symptoms of COPD in adults. COPD is a
long-term disease of the airways in the lungs,
which is often caused by cigarette smoking.

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE OXIS 12 TURBOHALER
Do not use Oxis Turbohaler:
• If you are allergic (hypersensitive) to formoterol,
or any of the other ingredients, of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using
Oxis Turbohaler if:
• You are diabetic. You may need some additional
blood sugar tests while you are using Oxis
Turbohaler.
• You have high blood pressure or you have ever
had a heart problem.
• You have problems with your thyroid gland.
• You have low levels of potassium in your blood.
Your doctor may take blood samples to check
the levels of potassium in your blood.
• You have severe liver problems such as liver
cirrhosis.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
Oxis Turbohaler.
Other medicines and Oxis Turbohaler
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines. This
is because Oxis Turbohaler can affect the way
some medicines work and some medicines
can have an effect on Oxis Turbohaler.
In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
• Beta-blocker medicines (such as atenolol or
propranolol for high blood pressure), including
eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such
as quinidine).
• Medicines like digoxin, often used to treat heart
failure.
• Diuretics, also known as ‘water tablets’ (such as
furosemide). These are used to treat high blood
pressure.
• Steroid medicines that you take by mouth (such
as prednisolone).
• Xanthine medicines (such as theophylline or
aminophylline). These are often used to treat
asthma.
• Erythromycin (used to treat infections).
• Anti-histamines (such as terfenadine).
• Other substances that dilate the airways
(bronchodilators, such as salbutamol).
• Ephedrine (used to treat asthma or as a
decongestant).
• Tricyclic anti-depressants (such as amitriptyline).
If any of the above applies to you, or if you are not
sure, talk to your doctor or pharmacist before
using Oxis Turbohaler.
Also tell your doctor or pharmacist if you are going
to have a general anaesthetic for an operation or
for dental work.

Also tell your doctor or pharmacist if you are going
to have a general anaesthetic for an operation or
for dental work.
The addition of anticholinergics (such as
tiotropium or ipratropium bromide) to the treatment
with Oxis Turbohaler, can help to open your
airways even more.
Pregnancy and breast-feeding
• If you are pregnant, or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor for advice before taking
this medicine - do not use Oxis Turbohaler
unless your doctor tells you to.
• If you get pregnant while using Oxis Turbohaler,
do not stop using Oxis Turbohaler but talk to
your doctor immediately.
Driving and using machines
Oxis Turbohaler is not likely to affect you being
able to drive or use any tools or machines.
Oxis Turbohaler contains lactose
Oxis Turbohaler contains lactose, which is a type
of sugar. If you have been told by your doctor that
you have an intolerance to some sugars, talk to
your doctor before using this medicine.
The amount of lactose in this medicine does not
normally cause problems in people who are
lactose intolerant.
The excipient lactose contains small amounts of
milk proteins, which may cause allergic reactions.
3. HOW TO USE OXIS 12 TURBOHALER





Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Do not increase the dose of Oxis Turbohaler
prescribed by your doctor without talking to your
doctor first.
If you are using Oxis Turbohaler regularly for
asthma or COPD you should continue to use
your medicine, even if you have no symptoms.

Important information about your asthma or
COPD symptoms
If you feel you are getting breathless or wheezy
while using Oxis Turbohaler, you should continue
to use Oxis Turbohaler but go to see your doctor
as soon as possible, as you may need additional
treatment.
Contact your doctor immediately if:
• Your breathing is getting worse or you often
wake up at night with asthma.
• You start getting chest tightness.
• You are not getting relief from your current
dose.
• You need to take more than your usual dose for
more than two days in a week.
• You need to use your Turbohaler more often
than usual before exercise.
These signs could mean that your asthma or
COPD is not being properly controlled and you
may need different or additional treatment
immediately.

Asthma
Oxis Turbohaler should not be used in children
under 6 years of age.
Adults (18 years and above)
• The recommended dose is 1 inhalation, once or
twice a day.
• Your doctor may increase this to 2 inhalations,
once or twice a day.
• Some people also use Oxis Turbohaler as a
‘reliever inhaler’. If you get asthma symptoms,
the usual dose is 1 inhalation when they
happen.
• A total daily dose of more than 4 inhalations is
not normally needed. This includes the
inhalations that you take every day, when you
get asthma symptoms and before exercise.
However, your doctor may allow you to take up
to 6 inhalations a day. Do not use more than
6 inhalations in total in 24 hours.
• Do not take more than 3 inhalations at any one
time.
Children and adolescents (6 to 17 years)
• The recommended dose is 1 inhalation once or
twice a day.
• Some children also use Oxis Turbohaler as a
‘reliever inhaler’. If your child gets asthma
symptoms, the usual dose is 1 inhalation when
they happen.
• A total daily dose of more than 2 inhalations is
not normally needed. This includes the
inhalations that your child takes every day,
when they get asthma symptoms and before
exercise. However, your doctor may allow
your child to take up to 4 inhalations a day. Your
child should not use more than 4 inhalations in
total in 24 hours.
• Your child should not have more than 1
inhalation at any one time.
Your doctor (or asthma nurse) will help you to
manage your asthma. Once your asthma is well
controlled your doctor may consider it appropriate
to gradually reduce the dose of Oxis Turbohaler.
Asthma caused by exercise
If you or your child have asthma symptoms
caused by exercise, your doctor may advise you
or your child to use Oxis Turbohaler before
exercise as well. Oxis Turbohaler should not be
used in children under 6 years of age.
Adults (18 years and above)
• The recommended dose is 1 inhalation before
exercise.
• A total daily dose of more than 4 inhalations is
not normally needed. This includes the
inhalations that you take every day, when you
get asthma symptoms and before exercise.
However, your doctor may allow you to take up
to 6 inhalations a day. Do not use more than
6 inhalations in total in 24 hours.
• Do not take more than 3 inhalations at any one
time.

Children and adolescents (6 to 17 years)
• The recommended dose is 1 inhalation before
exercise.
• A total daily dose of more than 2 inhalations is
not normally needed. This includes the
inhalations that your child takes every day, when
they get asthma symptoms and before exercise.
However, your doctor may allow your child to
take up to 4 inhalations a day. Your child should
not use more than 4 inhalations in total in 24
hours.
• Your child should not have more than 1
inhalation at any one time
Chronic obstructive pulmonary disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 1 inhalation once or twice a
day.
• Your doctor may advise you to take extra doses
for relief of your COPD symptoms.
• You should not have more than 4 inhalations a
day.
• Do not take more than 2 inhalations at any one
time.
Preparing your new Oxis Turbohaler
Before using your new Oxis Turbohaler for the
first time, you need to prepare it for use as
follows:
• Unscrew the white cover and
lift it off. You may hear a
rattling sound.
• Hold your Oxis Turbohaler
upright with the jade green
grip at the bottom.
• Turn the jade green grip as
far as it will go in one
direction. Then turn it as far
as it will go in the other
direction (it does not matter
which way you turn first).
You should hear a click
sound.
• Do this again, turning the
jade green grip in both
directions.
• Your Oxis Turbohaler is now
ready for use.

How to take an inhalation
Every time you need to take an inhalation, follow
the instructions below.
1 Unscrew the white cover and lift it off.
2 Hold your Turbohaler upright with the
jade green grip at the bottom.
3 Do not hold the mouthpiece when you load your
Turbohaler. To load your Turbohaler with a
dose, turn the jade green grip as far as it will go
in one direction. Then turn it as far as it will go in
the other direction (it does not matter which way
you turn it first). You should hear a click sound.
Your Turbohaler is now loaded and ready to use.
It is not possible to overload your Turbohaler
even if you turn the grip several times. Only load
your Turbohaler when you need to use it.

4.Hold your Turbohaler away from your mouth.
Breathe out gently (as far as is comfortable).
Do not breathe out through your Turbohaler.
5.Place the mouthpiece gently
between your teeth.
Close your lips. Breathe in
as deeply and as
hard as you can through
your mouth. Do not
chew or bite on the
mouthpiece.
6.Remove your Turbohaler from your mouth.
Then breathe out gently. The amount of
medicine that is inhaled is very small. This
means you may not be able to taste it after
inhalation. If you have followed the instructions,
you can still be confident that you have inhaled
the dose and the medicine is now in your lungs.
7 If you are to take a second inhalation, repeat
steps 2 to 6.
8 Replace the cover tightly after use.
Do not try to remove or twist the mouthpiece. It is
fixed to your Turbohaler and must not be taken off.
Do not use your Turbohaler if it has been
damaged or if the mouthpiece has come apart
from your Turbohaler.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week
with a dry tissue. Do not use water or liquids.
When to start using a new Turbohaler
• The dose indicator tells you how many
doses are left in the Turbohaler,
starting with 60 doses when it is
full.
• The dose indicator is marked in
intervals of 10 doses. Therefore, it
does not show every dose. When
you first see a red mark at the
edge of the indicator window, there
are approximately 20 doses left.
For the last 10 doses, the
background of the dose
indicator is red. When the ‘0’ on
the red background has reached
the middle of the window, you must
start using your new Turbohaler.
Note:
• The grip will still twist and ‘click’ even when your
Turbohaler is empty.
• The sound that you hear as you shake your
Turbohaler is produced by a drying agent and
not the medicine. Therefore the sound does not
tell you how much medicine is left in your
Turbohaler.
• If you load your Oxis Turbohaler more than once
by mistake before taking your dose, you will still
only receive one dose. However, the dose
indicator will register all the loaded doses.
If you use more Oxis Turbohaler than you
should
If you use more Oxis Turbohaler than you should,
contact your doctor or pharmacist for advice
immediately. The following effects may happen:
trembling, headache or a rapid heart beat.

Ref: 0862/230615/1/B

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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